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Janssen Reports Top-Line Phase 3 Results for TREMFYA® (guselkumab) in Adults with Active Psoriatic Arthritis

June 14, 2019 Off By BusinessWire

Data are part of the DISCOVER 1 and 2 programme, the first Phase 3
studies to evaluate a selective IL-23 p19 inhibitor in the treatment of
psoriatic arthritis

HORSHAM, Pa.–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today
announced top-line results from the Phase 3 DISCOVER 1 and 2 studies,
which evaluated the efficacy and safety of guselkumab compared to
placebo in adult patients with active moderate to severe psoriatic
arthritis (PsA). Both studies met their primary endpoints of American
College of Rheumatology 20% improvement (ACR20), and the safety profiles
observed for guselkumab in the DISCOVER programme were consistent with
previous studies of guselkumab and current prescribing information.¹

The DISCOVER programme comprises the first-ever Phase 3 studies
evaluating an IL-23 p19 inhibitor for the treatment of psoriatic
arthritis, and data will be presented at upcoming scientific medical
meetings. Data from the two DISCOVER studies will serve as the basis of
submissions to the U.S. Food and Drug Administration and European
Medicines Agency seeking approval of guselkumab as a treatment for
psoriatic arthritis, which are anticipated for later this year.

The DISCOVER programme consists of DISCOVER-1 and DISCOVER-2, two
randomised, double-blind, multicentre Phase 3 studies designed to
evaluate efficacy and safety of subcutaneous guselkumab in patients with
active PsA compared to placebo. In addition to the primary endpoint of
ACR20 response at week 24, multiple secondary endpoints were assessed
that included ACR50/70, resolution of soft tissue inflammation
(enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement
in physical function (HAQ-DI), skin clearance (IGA), and quality of life
(SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural
damage (vdH-S) as a key secondary endpoint.¹

DISCOVER-1 included 381 participants, including participants previously
treated with biologic anti-TNF biologics. The study continues through 52
weeks. DISCOVER-2 included 739 bio-naive participants and continues
through 100 weeks.

#ENDS#

About Psoriatic Arthritis (PsA)

PsA is a chronic, immune-mediated inflammatory disease characterised by
both joint inflammation and the skin lesions associated with psoriasis.²It is estimated that one third of the 125 million people who are
living with psoriasis worldwide will also develop PsA.³ The
disease causes pain, stiffness and swelling in and around the joints and
commonly appears between the ages of 30 and 50, but can develop at any
time.² Though the exact cause of PsA is unknown, genes, the
immune system and environmental factors are all believed to play a role
in the onset of the disease.²

About guselkumab⁴

On 10 November 2017, TREMFYA^® (guselkumab) was granted market
authorisation in the European Union (EU) for the treatment of adult
patients with moderate to severe plaque psoriasis who may benefit from
taking injections or pills (systemic therapy).⁴

Guselkumab is the first psoriasis treatment licensed in the EU to
selectively target IL-23, a key driver of the immune inflammatory
response in psoriasis.^5,6,7,8Guselkumab is a subcutaneous,
self-injectable treatment for psoriasis (following training). Treatment
requires two starter doses, one initially and the other four weeks
later, followed by a maintenance dose once every eight weeks (q8w)
thereafter.^5,6,9

Ongoing trials include: two Phase 3 programmes evaluating guselkumab in
the treatment of active PsA and a Phase 2b programmes in Crohn’s
disease, and two Phase 2 programmes – one for the treatment of
ulcerative colitis and the other for the treatment of hidradenitis
suppurativa.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain
exclusive worldwide marketing rights to TREMFYA^®which is
currently approved in the US, Canada and the EU.

Prescribing and safety information

For complete EU prescribing and safety information, please visit: https://www.medicines.org.uk/emc/medicine/34321

About the Janssen Pharmaceutical Companies of
Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the
past. We’re the Pharmaceutical Companies of Johnson & Johnson, working
tirelessly to make that future a reality for patients everywhere by
fighting sickness with science, improving access with ingenuity, and
healing hopelessness with heart. We focus on areas of medicine where we
can make the biggest difference: Cardiovascular & Metabolism,
Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and
Pulmonary Hypertension.

Learn more at www.janssen.com/EMEA.
Follow us at www.twitter.com/JanssenEMEA.

Janssen-Cilag International NV, the marketing authorisation holder for
TREMFYA^® in the EU, and Janssen Research & Development, LLC,
are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined
in the Private Securities Litigation Reform Act of 1995 regarding new
study data on guselkumab. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialise,
actual results could vary materially from the expectations and
projections of Janssen-Cilag International NV and Janssen Research &
Development, LLC. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in behaviour
and spending patterns of purchasers of health care products and
services; changes to applicable laws and regulations, including global
health care reforms; and trends toward health care cost containment. A
further list and descriptions of these risks, uncertainties and other
factors can be found in Johnson & Johnson’s Annual Report on Form 10-K
for the fiscal year ended 30 December, 2018, including in the sections
captioned “Cautionary Note Regarding Forward-Looking Statements” and
“Item 1A. Risk Factors,” and in the company’s most recently filed
Quarterly Report on Form 10-Q, and the company’s subsequent filings with
the Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.

# # #

¹ Janssen Pharmaceutical Companies of Johnson & Johnson. Data
on file (2019).

² Mayo Clinic. Psoriatic Arthritis. http://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/home/ovc-20233896.
Accessed June 2019.

³ International Federation of Psoriasis Associations. Our
Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/.
Accessed June 2019.

⁴ European Medicines Agency. Tremfya 100mg solution for
injection. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321.
Accessed June 2019.

⁵ Blauvelt A, et al. Efficacy and safety of
guselkumab, an anti-interleukin-23 monoclonal antibody, compared with
adalimumab for the continuous treatment of patients with moderate to
severe psoriasis: Results from the phase III, double-blinded, placebo-
and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol
2017;76(3):405–17.

⁶ Reich K, et al. Efficacy and safety of guselkumab,
an anti-interleukin-23 monoclonal antibody, compared with adalimumab for
the treatment of patients with moderate to severe psoriasis with
randomized withdrawal and retreatment: Results from the phase III,
double-blind, placebo- and active comparator-controlled VOYAGE 2 trial.
J Am Acad Dermatol 2017;76(3):418–31.

⁷ Langley R, et al. Efficacy and safety of guselkumab
in patients with psoriasis who have an inadequate response to
ustekinumab: results of the randomized, double-blind, phase III NAVIGATE
trial. Br J Dermatol 2018;178(1):114–23.

⁸ Bachelez, H. Interleukin 23 inhibitors for psoriasis: not
just another number. The Lancet 2017;390(10091):208–10.

⁹ ClinicalTrials.gov. A Study to Evaluate the Comparative
Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of
Moderate to Severe Plaque-type Psoriasis (ECLIPSE). Identifier
NCT03090100. Available at: https://clinicaltrials.gov/ct2/show/NCT03090100.
Accessed June 2019.